• In cluster randomized trials (CRTs), the units of allocation, intervention, and outcome measurement may differ within a single trial. As a result of the unique design of CRTs, the interpretation of existing research ethics guidelines is complicated.
• The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials aims to provide researchers and research ethics committees (RECs) with detailed guidance on the ethical design, conduct, and review of CRTs.
• A five-year mixed methods research project explored the ethical challenges of CRTs. Empirical studies documented the reporting of ethical issues in published CRTs, interviewed experienced trialists, and surveyed trialists and REC chairs. The ethical issues identified were explored in a series of background papers that provided detailed ethical analyses and policy options, and a panel of experts using a systematic process developed a consensus statement.
• The Ottawa Statement sets out 15 recommendations for the ethical design and conduct of CRTs. The recommendations provide guidance on the justification of a cluster randomized design, the need for REC review, the identification of research participants, obtaining informed consent, the role of gatekeepers in protecting group interests, the assessment of benefits and harms, and the protection of vulnerable participants.

METHODS: We conducted the National Emergency Department Safety Study in 62 urban EDs across 20 US states. We reviewed 9,821 medical records of ED patients with one of 3 conditions (myocardial infarction, asthma exacerbation, and joint dislocation) to evaluate medical errors. We also obtained surveys from 3,562 staff randomly selected from each ED; survey data were used to calculate average safety climate scores for each ED.

RESULTS: We identified 402 adverse events (incidence rate 4.1 per 100 patient visits; 95% confidence interval [CI] 3.7 to 4.5) and 532 near misses (incidence rate 5.4 per 100 patient visits; 95% CI 5.0 to 5.9). We judged 37% of the adverse events, and all of the near misses, to be preventable (errors); 33% of the near misses were intercepted. In multivariable models, better ED safety climate was not associated with fewer preventable adverse events (incidence rate ratio per 0.2-point increase in ED safety score 0.82; 95% CI 0.57 to 1.16) but was associated with more intercepted near misses (incidence rate ratio 1.79; 95% CI 1.06 to 3.03). We found no association between safety climate and violations of national treatment guidelines.

CONCLUSION: Among the 3 ED conditions studied, medical errors are relatively common, and one third of adverse events are preventable. Improved ED safety climate may increase the likelihood that near misses are intercepted. Inc. All rights reserved.

OBJECTIVE: To assess differences between self seekers versus those that act also as surrogate seekers.

METHODS: We analyzed data from the cross-sectional Pew Internet and American Life Project November/December 2008 health survey. Our dependent variable was self-report of type of health information seeking (surrogate versus self seeking). Independent variables included demographics, health status, and caregiving. After bivariate comparisons, we then developed multivariable models using logistic regression to assess characteristics associated with surrogate seeking.

RESULTS: Out of 1250 respondents who reported seeking health information online, 56% (N=705) reported being surrogate seekers. In multivariable models, compared with those who sought information for themselves only, surrogate seekers were more likely both married and a parent (OR=1.57, CI=1.08, 2.28), having good (OR=2.05, CI=1.34, 3.12) or excellent (OR=2.72, CI=1.70, 4.33) health status, being caregiver of an adult relative (OR=1.76, CI=1.34, 2.30), having someone close with a serious medical condition (OR=1.62, CI=1.21, 2.17) and having someone close to them facing a chronic illness (OR=1.55, CI=1.17, 2.04).

CONCLUSIONS: Our findings provide evidence that information needs of surrogate seekers are not being met, specifically of caregivers. Additional research is needed to develop new functions that support surrogate seekers.

BACKGROUND: Hypertrabeculation has been associated with adverse cardiovascular events, but the distribution and clinical correlates of the volume and mass of the TPM in a normal left ventricle have not been well characterized.

METHODS: Short-axis cine cardiac magnetic resonance images, obtained using a steady-state free precession sequence from 1,494 members of the Framingham Heart Study Offspring cohort, were analyzed with software that automatically segments TPM. Absolute TPM volume, TPM as a fraction of end-diastolic volume (EDV) (TPM/EDV), and TPM mass as a fraction of LV mass were determined in all offspring and in a referent group of offspring free of clinical cardiovascular disease and hypertension.

RESULTS: In the referent group (mean age 61 +/- 9 years; 262 men and 423 women), mean TPM was 23 +/- 3% of LV EDV in both sexes (p = 0.9). TPM/EDV decreased with age (p < 0.02) but was not associated with body mass index. TPM mass as a fraction of LV mass was inversely correlated with age (p < 0.0001), body mass index (p < 0.018), and systolic blood pressure (p < 0.0001). Among all 1,494 participants (699 men), LV volumes decreased 23%, LV mass increased 28%, and EF increased by 7.5 EF units (p < 0.0001) when TPM were considered myocardial mass rather than part of the LV blood pool.

CONCLUSIONS: Global cardiac magnetic resonance LV parameters were significantly affected by whether TPM was considered as part of the LV blood pool or as part of LV mass. Our cross-sectional data from a healthy referent group of adults free of clinical cardiovascular disease demonstrated that TPM/EDV decreases with increasing age in both sexes but is not related to hypertension or obesity. Elsevier Inc. All rights reserved.

MATERIALS AND METHODS: We studied 102,395 patients who received 158,511 person-years of warfarin treatment from the Veterans Health Administration (VA) between 10/1/06-9/30/08. We constructed a list of ICD-9-CM codes of "candidate" bleeding events. Each candidate event was identified as a major hemorrhage if it fulfilled one of four criteria: 1) associated with death within 30days; 2) bleeding in a critical anatomic site; 3) associated with a transfusion; or 4) was coded as the event that precipitated or was responsible for the majority of an inpatient hospitalization.

RESULTS: This definition classified 11,240 (15.8%) of 71, 338 candidate events as major hemorrhage. Typically, events more likely to be severe were retained at higher rates than those less likely to be severe. For example, Diverticula of Colon with Hemorrhage (562.12) and Hematuria (599.7) were retained 46% and 4% of the time, respectively. Major, intracranial, and fatal hemorrhage were identified at rates comparable to those found in randomized clinical trials however, higher than those reported in observational studies: 4.73, 1.29, and 0.41 per 100 patient years, respectively.

CONCLUSIONS: We describe here a workable definition for identifying major hemorrhagic events from large automated datasets. This method of identifying major bleeding may have applications for quality measurement, quality improvement, and comparative effectiveness research.

METHODS: We studied long-term oral anticoagulation care for 56,490 patients aged 65 years and older at 100 sites of care in the Veterans Health Administration. We used the rate of gaps in monitoring per patient-year to predict percentage time in therapeutic range (TTR) at the 100 sites.

RESULTS: Many patients (45%) had at least one gap in monitoring during an average of 1.6 years of observation; 5% had two or more gaps per year. The median gap duration was 74 days (interquartile range, 62-107). The average TTR for patients with two or more gaps per year was 10 percentage points lower than for patients without gaps (P andlt; .001). Patient-level predictors of gaps included nonwhite race, area poverty, greater distance from care, dementia, and major depression. Site-level gaps per patient-year varied from 0.19 to 1.78; each one-unit increase was associated with a 9.2 percentage point decrease in site-level TTR (P andlt; .001).

CONCLUSIONS: Site-level gap rates varied widely within an integrated care system. Sites with more gaps per patient-year had worse anticoagulation control. Strategies to address and reduce gaps in monitoring may improve anticoagulation control.

SETTING: Four participating health plans within the National Heart, Lung, and Blood Institute-sponsored Cardiovascular Research Network.

PARTICIPANTS: All members aged 65 and older with HF based on hospital discharge and ambulatory visit diagnoses.

MEASUREMENTS: Participants with a LVEF of 50% or greater were classified as having HF-P. Presence of cardiac and noncardiac comorbidities was obtained from health plan administrative databases.

RESULTS: Of 23,435 individuals identified with HF and LVEF information, 53% (12,407) had confirmed HF-P (mean age 79.6; 60% female). More than three-quarters of the sample had three or more co-occurring conditions in addition to HF, and half had five or more cooccurring conditions. Participants with HF-P had a slightly higher burden of comorbidity than those with HF-R (mean 4.5 vs 4.4, P = .002). Patterns of how specific conditions co-occurred did not vary in participants with preserved or reduced systolic function.

CONCLUSION: There is a high degree of comorbidity and multiple morbidity in individuals with HF. The burden and pattern of comorbidity varies only slightly in individuals with preserved or reduced LVEF. Geriatrics Society.

OBJECTIVE: To evaluate the diagnostic yield of VCE and rate of therapeutic intervention for OOGIB for inpatients and outpatients with respect to timing of the intervention.

DESIGN: Retrospective cohort study.

SETTING: Tertiary academic center.

PATIENTS: Patients who had VCE for OOGIB between August 2008 and August 2010.

INTERVENTIONS: VCE for inpatients versus outpatients.

MAIN OUTCOME MEASURES: Diagnostic yield and rate of therapeutic intervention for inpatients versus outpatients.

RESULTS: One hundred forty-four inpatients (65 women) and 116 outpatients (49 women) were included. Diagnostic yield was 65.9% for inpatients versus 53.4% for outpatients (P = .054). Inpatients were divided into those who had VCE within 3 days (<3 >days; n = 90) of admission versus after 3 days (>3 days; n = 54). Active bleeding and/or an angioectasia was found in 44.4% of the 3-day group (P = .046) versus 25.8% of the outpatients. Therapeutic intervention was performed in 18.9% of the 3-day group (P = .046) versus 10.3% of outpatients. Diagnostic yield and therapeutic intervention rate between the >3-day group and outpatients were not significantly different. Length of stay (days) was less in the 3-day cohort (P < .0001).

LIMITATIONS: Long-term outcomes were not studied. This was a retrospective study.

CONCLUSIONS: Early deployment of VCE within 3 days of admission results in a higher diagnostic yield and therapeutic intervention rate and an associated reduction of length of stay. Mosby, Inc. All rights reserved.

DESIGN: National retrospective cohort study.

SETTING: VA Medical facilities.

PATIENTS: A total of 170,681 Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF) Veterans who sought care at VA medical facilities from April 2007 to September 30, 2008.

METHODS: Data were abstracted from VA administrative and operational databases, including patient demographics, facility characteristics, and outcomes.

MAIN OUTCOME MEASUREMENTS: The main outcomes were receipt of and results of the TBI screen.

RESULTS: The majority of veterans eligible received the TBI screen (91.6%). Screening rates varied by patient and facility characteristics. In all, 25% of screened veterans had probable TBI exposure, in which the majority of the exposures were blasts (85.0%). The rate of a positive TBI screen was 20.5% for the screened cohort. Male gender, service in the army, multiple deployments, and mental health diagnoses in the previous year were associated with a positive screen.

CONCLUSIONS: TBI screening rates are high in VA; concomitant mental health diagnoses were highly prevalent in individuals with positive TBI screens. These data indicate that there will be a significant need for long-term health care services for veterans with TBI symptomatology. Published by Elsevier Inc. All rights reserved.

STUDY DESIGN: A retrospective analysis using binary logistic regression and hierarchical linear models was run to evaluate independent predictors of prophylactic feeding tube placement.

METHODS: Surveillance, Epidemiology, and End Results-Medicare data were used. Head and neck cancer patients diagnosed with locoregionally advanced stage disease from 2000 to 2005 were included in this study (N = 8,306).

RESULTS: Across all models, prophylactic gastrostomy tube placement was found to be more likely in patients who had cancer of the larynx or oropharynx compared with those with cancer of the nasopharynx or oral cavity; who had regional instead of local cancer; who did not receive surgery as a part of treatment, but did receive chemotherapy; and who were divorced, separated, or widowed. Additionally, although practice variation was observed to occur, its overall contribution in predicting prophylactic gastrostomy tube placement was minimal.

CONCLUSIONS: As health care enters an era of patient-centered care, further investigation of the potential role of social support (or lack of social support) in influencing treatment decisions of head and neck cancer patients and providers is warranted. LEVEL OF EVIDENCE: 2b Laryngoscope, 2013. Society, Inc.